By Jennie Zeitler, Correspondent
Shaina Kloss Gottwalt is thrilled to be among the first patients approved to use a new drug to battle the effects of multiple sclerosis (MS). She just received her first course of treatment by infusion and is waiting to see how her body responds. The drug is Lemtrada.
Gottwalt grew up in Royalton, graduating in 1997. She and her husband, Joe, lived in Rice for eight years before building a house and chicken barn just west of Royalton in 2008. They have two daughters, Hayley, a student at Colorado State University and Cierra, an eighth grader at Royalton Middle School.
Multiple sclerosis manifests itself differently in each person who is diagnosed. Gottwalt’s major symptoms happened in her eyes, affecting her vision. She was diagnosed in February of 2003, when Cierra was six months old. In hindsight, she can see that her first symptoms had appeared when Hayley was six months old.
“I was on my way to work in 2003 and thought maybe I had soap in my eye,” Gottwalt said. “I could not see the colors of the stoplights.”
She saw the doctor that day and first heard the words “optic neuritis.” The doctor even mentioned a possible brain tumor. Gottwalt had an MRI and could tell “by the look on (the) face” of the technician that something was wrong.
She started taking steroids by IV that same day, a Friday. “They wouldn’t let me wait until Monday,” she said. “But by Saturday evening, my vision was back.”
Gottwalt was so convinced that life would never be the same that she took a trip to Cancun with her mother and Hayley. Back home again, she woke up with the same vision problem a couple weeks later. It was a few days after that she was told she was experiencing MS. Her symptoms are focused in her eyes with general fatigue and some overall numbness.
Until she started treatment with Lemtrada, Gottwalt had taken only three different medications. She had a weekly injection of Avonex (interferon beta-1a) for two years. Throughout the next six years she had an injection of Betaseron (interferon beta-1b) every other day. Then she had a monthly infusion of Tysabri.
Gottwalt is seen by Dr. Jonathan Calkwood at the Shapiro MS Center in Golden Valley. Shortly after her initial diagnosis, she began doing extensive research about treatments. After 11 months on the waiting list, she was first seen at the Center in 2006.
“I heard that Dr. Shapiro only saw MS patients,” said Gottwalt. “I wanted to go there.”
Shapiro is now retired, and Calkwood “sees more MS patients than any other doctor in the United States,” Gottwalt said.
Gottwalt’s optic nerve was found to be getting thinner, a major concern. She also tested positive for the John Cunningham (JC) virus, something that 70 – 90 percent of the world’s population has, according to Healthline.com.
“Being JCV positive could cause a brain infection called PML,” said Gottwalt. “That’s why we started looking for another treatment. But the only way to go was backward, to a less effective treatment than Tysabri. Tysabri was slowing the thinning of my optic nerve, but other treatments would not have been as effective.”
Although Gottwalt had been looking for alternatives for a while, it was in July of this year that the search for another treatment really gained momentum. She had a PML scare in which lesions were found on her brain during a routine MRI. In the end, it turned out not to be PML, but she needed something else soon.
Then Gottwalt learned about Lemtrada.
“Symptoms do tend to improve over the long haul (with Lemtrada),” Calkwood was quoted as saying in a press release in April. “Our goal really is to prevent long term disability.”
“Lemtrada was approved for use in December 2014,” Gottwalt said. “Every month after that I thought I would be able to get it, but my insurance was the hang-up. The insurance company approved me for it but would not set an allowable amount.”
Lemtrada is a drug administered via IV for five days. The patient then waits one year and receives the drug for three days. The cost for five days of treatment is $130,000.
Gottwalt was in contact with a nurse at the Center every three to four weeks from January through September. During that time, she was accepted into a program to help with treatment costs, the Assistance Fund based in Orlando, Fla. The fund helps with expenses for treatment involving 102 different drugs.
Due to the insurance conflicts, Gottwalt’s Lemtrada infusions were done at the University of Minnesota rather than at the Center. She and Joe were at the hospital all day for up to eight hours. The infusion itself took four hours and she was required to wait at the hospital afterwards for at least two hours, to be monitored for problems.
“My hope is that once next year’s three-day dose is done, I should not need to be on any drug for 10 years,” Gottwalt said. “Some people need a booster in between, but I’m hoping I don’t need that.”
Gottwalt should not require any medication between now and next year’s treatment.
One unique (but not unknown) aspect of Gottwalt’s treatment is that it was split by a weekend, with three days one week and two the next.
“The literature always says ‘five consecutive days’ and no one’s ever really given me an answer why it was split,” she said. “But I can see on Lemtrada’s website that I’m not the only one.”
Gottwalt was able to take a month off of her job as a radiology technician at CentraCare Health in St. Cloud as a precautionary measure. Every person entering the Gottwalt house is required to wash their hands first.
“The effects of the treatment are very similar to chemo and my white blood cell count went way down,” she said.
Gottwalt was cautioned about possible side effects, but so far, two weeks after her infusions ended, she has only experienced fatigue.
People in the trials for Lemtrada seven and eight years ago have reported amazing improvements in their condition.
“There was a lady who had been in a wheelchair for five years and was unemployed, went from a wheelchair to a walker to sometimes using a cane, 18 months after her second dose,” Gottwalt said. “She is now working again too.”
Gottwalt’s family has high hopes for her improvement as well.
“We hope the MS at least holds where it is, that there won’t be any more advance,” said Joe.
Gottwalt is also excited about news that trials will be starting soon for a STEM cell replacement therapy for MS patients.
“I just want to get the word out about Lemtrada,” she said. “There are so many people who could benefit. I want to tell people not to settle. If they are not absolutely happy with their neurologist or their treatment – find a new one.”